ResMed AirCurve 10 ST-A Bedienungsanleitung

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ResMed Ltd 2018.

DOC NO 288156

PAGE 1 of 130

SPECIFICATION

– PRINTED MATERIALS REV 1

Rev Change

Note

Date

document

drafted

Document prepared by

(Name)

Document Checked by

(Name)

1 K001608-00 24 July 2018 Melanie Theaker Lisa Oliver or delegate refer to change note.

AirCurve 10 ST-A User Guide AMER Multi

1. ORACLE DESCRIPTION

AirCurve10 ST-A UG AMER MULTI

2. TRANSLATION DESCRIPTION

Refer to the Change History on the English source listed for summary of changes in each version.

Rev English source This translation replaces…

1 288009r4 plus changes shown

below

288131

3. PRINT DETAILS

Print according to master spec R370-7240

4. RESMED QC INSPECTION

For general sampling and inspection requirements, refer to AWI203-002 Appendix A, Printed or Unprinted

Materials and Labels, Criteria 1, 2, 3, 4, 5, 6, 8 and 9

Additional requirement

a) None

5. FOR ALL OTHER REQUIREMENTS, REFER TO RESMED SUPPLIER MANUAL AQP119.

6. CHANGE HISTORY

Section Update

Tech

Specs

Update of Wireless approval certificate id to add information for 4G

FCC ID: 2ACHL-AIR104G

IC ID: 9103A-AIR104G

Tech

Specs

Update of Classification to be IEC 60601-1:2005+A1:2012

Tech

Specs

Update of Wireless information to match Machine data for Tech comms rev

Cleaning Add warning ‘Regularly clean the tubing assembly, water tub and mask for

optimal therapy and to prevent the growth of germs that can adversely the

patient’s health.

User guide

English | Français | Español | Português

288156 covers.indd 2 24/07/2018 12:09:57 PM

288156 covers.indd 3 24/07/2018 12:09:57 PM

English 1

ENGLISH

Welcome

The AirCurve™10 ST-A is a bilevel positive airway pressure device.

WARNING

Read this entire guide before using the device.

CAUTION

In the US, Federal law restricts this device to sale by or on the order of a physician.

Indications for use

AirCurve 10 ST-A

The AirCurve 10 ST-A is indicated to provide non-invasive ventilation for patients weighing more

than 30 lb (13 kg) with respiratory insufficiency or obstructive sleep apnea (OSA).

The iVAPS mode is indicated for patients weighing more than 66 lb (30 kg).

The AirCurve 10 ST-A is intended for home and hospital use.

The humidifier is intended for single patient use in the home environment and re-use in a

hospital/institutional environment.

Contraindications

Positive airway pressure therapy may be contraindicated in some patients with the following pre-

existing conditions:

•severe bullous lung disease

•pneumothorax or pneumomediastinum

•pathologically low blood pressure, particularly if associated with intravascular volume depletion

•dehydration

•cerebrospinal fluid leak, recent cranial surgery, or trauma.

Adverse effects

You should report unusual chest pain, severe headache, or increased breathlessness to your

prescribing physician. An acute upper respiratory tract infection may require temporary

discontinuation of treatment.

The following side effects may arise during the course of therapy with the device:

•drying of the nose, mouth, or throat

•nosebleed

•bloating

•ear or sinus discomfort

•eye irritation

•skin rashes.

At a glance

The AirCurve 10 includes the following:

•Device with HumidAir™integrated humidifier

•Water tub

•Air tubing

•Power supply unit

•Travel bag

•SD card (already inserted).

Contact your care provider for a range of accessories available for use with the device including:

•Air tubing (heated and non-heated): ClimateLineAir™, ClimateLineAir Oxy, SlimLine™, Standard

•Water tub: Standard water tub, cleanable water tub (can be disinfected)

•Side cover for use without the humidifier

•Filter: Hypoallergenic filter, standard filter

•Air10™DC/DC converter (12V/24V)

•SD card reader

•Air10 oximeter adapter

•Air10 USB adapter

•Power Station II

•Air10 tubing elbow

English 3

About your device

Air outlet

HumidAir humidifier (water tub)

Air filter cover

Screen

Retention clip

Adapter cover

Power inlet

SD card cover

Serial number and device number

LED alarm indicator

About the control panel

Start/Stop button

Press to start/stop therapy.

Press and hold for three seconds to enter power save

mode.

Dial

Turn to navigate the menu and press to select an option.

Turn to adjust a selected option and press to save your

change.

Home button Press to return to the Home screen.

Different icons may be displayed on the screen at different times including:

Ramp Time Wireless signal strength (green)

Humidity Wireless transfer not enabled (gray)

Humidifier warming No wireless connection

Humidifier cooling Airplane Mode

Alarm muted

Setup

CAUTION

Do not overfill the water tub as water may enter the device and air tubing.

1. With the device on a stable level surface, grip the retention clip on the back of the device and

pull up to open. Note: The retention clip is shown in the open position.

2. (a) Plug the power connector into the device power inlet then (b) push down the retention clip to

secure in place. Connect one end of the power cord into the power supply unit and the other end

into the power outlet.

3. Connect the air tubing firmly to the air outlet located on the rear of the device.

4. Open the water tub and fill it with distilled water up to the maximum water level mark.

Do not fill the water tub with hot water.

5. Close the water tub and insert it into the side of the device.

6. Connect the free end of the air tubing firmly onto the assembled mask.

See the mask user guide for detailed information.

Recommended masks are available on www.resmed.com.

Note: Ensure the device is placed so that the LED alarm indicator is clearly visible.

English 5

Starting therapy

1. Fit your mask.

2. Press Start/Stop or breathe normally if SmartStart™is enabled.

You will know that therapy is on when the Monitoring screen is displayed.

The pressure bar shows the inspiratory and expiratory pressures in green.

The green bar will expand and contract as you breathe in and out.

The screen will go black automatically after a short period of time. You can press Home or the dial to

turn it back on. If power is interrupted during therapy, the device will automatically restart therapy

when power is restored.

The AirCurve 10 device has a light sensor that adjusts the screen brightness based on the light in

the room.

Stopping therapy

1. Remove your mask.

2. Press Start/Stop or if SmartStart is enabled, therapy will stop automatically after a few seconds.

Note: If Confirm Stop is enabled, a message is displayed asking if you want to stop therapy. Turn

the dial to select Yes and then press the dial to stop therapy.

Once therapy has stopped, the Sleep Report gives you a summary of your therapy session.

Usage hours–Indicates the number of hours of therapy you received last

session.

Mask Seal–Indicates how well your mask sealed:

Good mask seal.

Needs adjusting, see Mask Fit.

Humidifier–Indicates if your humidifier is working properly:

Humidifier working.

Humidifier might be faulty, contact your care provider.

If set by your care provider, you will also see:

Events per hour–Indicates the number of apneas and hypopneas experienced per hour.

More Info–Turn the dial to scroll down to view more detailed usage data.

Power save mode

Your AirCurve 10 device records your therapy data. In order to allow it to transmit the data to your

care provider, you should not unplug the device. However, you can put it into power save mode to

save electricity.

To enter power save mode:

•Press and hold Start/Stop for three seconds.

The screen goes black.

To exit power save mode:

•Press Start/Stop once.

The Home screen is displayed.

My Options

Your AirCurve 10 device has been set up for your needs by your care provider, but you may find you

want to make small adjustments to make your therapy more comfortable.

Highlight My Options and press the dial to see your

current settings. From here, you can personalize your

options.

Ramp Time

Designed to make the beginning of therapy more comfortable, Ramp Time is the period during

which the pressure increases from a low start pressure to the prescribed treatment pressure.

You can set your Ramp Time to Off or between 5 to 45 minutes.

To adjust Ramp Time:

1. In My Options, turn the dial to highlight Ramp

Time and then press the dial.

2. Turn the dial to adjust the ramp time to your

preferred setting and press the dial to save the

change.

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